Study to compare laparoscopic RYGB with LMGB

Researchers from the Limmattal Hospital in Zurich-Schlieren, Switzerland, have begun recruitment into a study that is comparing laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic mini gastric bypass (LMGB). Although LRYGB is considered the gold standard in bariatric surgery, LMGB is increasing its popularity with similar results to LRYGB in terms of weight loss and comorbidity resolution. However, the researchers state that there is a lack of randomised controlled trials (RCT) comparing LMGB and LRYGB, and that this current study may “have the potential to influence bariatric surgery guidelines profoundly and may bring additional insights in the pathophysiology of the intestinal tract after bariatric surgery.”

The trial protocol, ‘Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial’, was published in BMC Obesity. This RCT is a single centre, patient and observer blinded trial. The study is conducted as a non-inferiority trial with researchers hoping to demonstrate that LMGB is not inferior to LRYGB in terms of excess weight loss (EWL).

“The RCT will also answer some important questions about LMGB, such as the course of obesity-related comorbidities and dumping syndrome,” the authors write. “Furthermore, this study addresses the postoperative course of hormones and lipids in these two different bariatric procedures.”

The primary endpoint in the trial is EWL 12 months after surgery, whereas three-year EWL, morbidity, mortality, remission of obesity related comorbidities, quality of life (QOL) and hormonal and lipid profile changes are secondary endpoints. The study is aiming to recruit 80 patients (40 patients in each treatment arm) with a BMI between 35-50 who meet the Swiss guidelines for the surgical treatment of morbid obesity. Pre-operatively, all patients will be assessed by a nutritionist, endocrinologist, psychiatrist and general surgeon. The endpoints and baseline measurements will be assessed pre-surgery, peri-surgery and post-surgery (fixed follow up measurements are at discharge and at the time points six weeks and 12 and 36;months postoperatively). The study's planned visit and examination schedule is shown in Figure 1.

“The perfect bariatric procedure is technically easy and safe, and leads to adequate EWL and improvement in obesity-related comorbidities. In contrast to the widely used LRYGB and LSG, the LMGB might fulfill all of these criteria,” the authors conclude. “The current study will answer questions about safety, effectiveness and pathophysiological changes in obesity-relevant hormones and lipids after LMGB. These findings might therefore influence decision-making in bariatric surgery implementing current surgical protocols towards personalized indications.”

The trial has received ethics approval and enrolment in the trial is ongoing.